510(k) · Decided

Recalled · Class II · 2015

Perifix Pediatric Epidural Kit

K962696510(k) TraditionalDecided Apr 3, 1997266-day reviewClass II21 CFR 868.5140Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

B.Braun Medical, Inc. · CAZ Anesthesia Conduction Kit

Cleared on Apr 3, 1997 as substantially equivalent to K813186 (Burron Medical Products, Inc., 1981) and 2 other predicates after a 266-day review. Its family tree reaches back 1 generation to 1981. 3 later devices descend from it. It has been recalled once.

Decided: Apr 3, 1997
Review: 266 days
Class: Class II
Product code: CAZ
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K813186 (1981). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
This deviceK962696 Perifix Pediatric Epidural KitB.Braun Medical, Inc. · 1997
Descendant · cites it directly · 2 of its ownK033080 Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterPortex, Inc. · 2004
Descendant · cites it directly · 1 of its ownK062902 Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie · 2007
Descendant · 2 generations on · 0 of its ownK090884 Perifix One Pediatric Catheter, 20 GA. & 24 GA.B.Braun Medical, Inc. · 2009

Most influential descendants

Showing 3 of 3 · See all

K033080Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterPortex, Inc. · 2004 · cites it directly2descendants
K062902Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie · 2007 · cites it directly1descendant
K090884Perifix One Pediatric Catheter, 20 GA. & 24 GA.B.Braun Medical, Inc. · 2009 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K813186	Perfix Set for Epidural Anesthesia W/Tuo	Burron Medical Products, Inc.	1981	—
0 (this device)	K962696	Perifix Pediatric Epidural Kit	B.Braun Medical, Inc.	1997	—
+1	K033080	Portex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter	Portex, Inc.	2004	—
+1	K062902	Pajunks Epilong Set Pediatric	PAJUNK GmbH Medizintechnologie	2007	—
+2	K090884	Perifix One Pediatric Catheter, 20 GA. & 24 GA.	B.Braun Medical, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0
2009	1	0

FIG. 1 — Lineage of K962696, 1981–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CAZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CAZ device

#1 K261372 Profoject™ LOR Syringescore 12.4 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K813186	Perfix Set for Epidural Anesthesia W/Tuo Summary page 1 …esia Kit CLASSIFICATION NAME: Anesthesiology Class II, 73 CAZ, Conduction Anesthesia Kit 21 CFR 868.5140° SUBSTANTIAL EQUIVALENCE' TO: 510(k) number Name Applicant K813186 Perifix Set for \| Burron Medical Epidural Anesthesia K893766 Lifecare Epidural Abbott Catheter K953467 Spinal Anesthesia Becton…	Burron Medical Products, Inc.	1981	—
*	K893766	Lifecare Cont. Epidural Cath. for Morphine Sulfate Summary page 1 …Z, Conduction Anesthesia Kit 21 CFR 868.5140° SUBSTANTIAL EQUIVALENCE' TO: 510(k) number Name Applicant K813186 Perifix Set for \| Burron Medical Epidural Anesthesia K893766 Lifecare Epidural Abbott Catheter K953467 Spinal Anesthesia Becton Dickinson Tray DEVICE DESCRIPTION: In accordance with secti…	Abbott Laboratories	1989	—
*	K953467	B-D Spinal Anesthesia Tray Spinal Summary page 1 …40° SUBSTANTIAL EQUIVALENCE' TO: 510(k) number Name Applicant K813186 Perifix Set for \| Burron Medical Epidural Anesthesia K893766 Lifecare Epidural Abbott Catheter K953467 Spinal Anesthesia Becton Dickinson Tray DEVICE DESCRIPTION: In accordance with section 510(k) for the Federal Food, Drug, and C…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1995	—

Also cleared against K813186: 8 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033080	Portex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter	Portex, Inc.	2004	2
K062902	Pajunks Epilong Set Pediatric	PAJUNK GmbH Medizintechnologie	2007	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 27, 2015	Class II	Z-0150-2016	Under Investigation by firm	Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K033080 (Portex, Inc., 2004) has gone furthest, with 2 descendants of its own.
8 other devices also cite its predicate K813186.

How does its category compare?

All CAZ devices

CAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAZ

1in 2023

2007high 9 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAZ

108in 2012

2007high 172 (2007) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAZ

1in 2024

2007high 29 (2009) · low 0 (2007)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · CAZ

137in 2025

2007high 472 (2019) · low 60 (2023)2025

MAUDE reports naming product code CAZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	172	0	81
2008	4	99	0	80
2009	2	—	29	134
2010	2	—	8	139
2011	1	—	2	187
2012	9	108	0	187
2013	0	—	12	276
2014	0	—	2	251
2015	1	—	1	235
2016	2	—	1	372
2017	0	—	0	353
2018	0	—	0	448
2019	1	—	0	472
2020	1	—	0	274
2021	1	—	0	165
2022	1	—	0	270
2023	1	—	0	60
2024	0	—	1	165
2025	0	—	0	137
2026	1	—	12 (11)	—

What is it indicated for?

The Perifix Pediatric Epidural Kit is designed to provide pediatric patients, who are undergoing a surgical procedure, with regional anesthesia below the level of the tenth thoracic vertebrae.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K962696 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962696: Perifix Pediatric Epidural Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962696

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026